ICH Q7 Good manufacturing practice for active pharmaceutical ingredients

Current effective version

PDF iconAdopted guideline

Reference numberCPMP/ICH/365/96
Published01/11/2000
Effective from01/11/2000
KeywordsGood manufacturing practice, active pharmaceutical ingredients (APIs), quality
DescriptionThis document provides guidance on the good manufacturing practice for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It also aims to help ensure that APIs meet the requirements for quality and purity.


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